QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE)— 510(k) K113744

Name: FDA 510(k) clearance K113744
Creator: U.S. Food and Drug Administration
Published: 2012-02-01

Substantially Equivalent

Angiotech

FDA 510(k) clearance K113744 for QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE), Substantially Equivalent on 2012-02-01. Applicant: Angiotech. Device class: 2.

Clearance details

Applicant: Angiotech
Product code: Product code NEW
Device class: Class 2
Regulation: 21 CFR 878.4840
Advisory panel: General, Plastic Surgery
Date received: 2011-12-20
Decision date: 2012-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NEW

product code NEW

Death: 32
Injury: 2,179
Malfunction: 8,975
Total: 11,186

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.